Direct Oral Anticoagulant removal by a DOAC filter: Impact on lupus anticoagulant testing - Evaluation on spiked and patient samples.

BACKGROUND

DOAC Filter (DF) is a new device to overcome interference in lupus anticoagulant (LAC) testing by direct oral anticoagulants (DOACs).

OBJECTIVES

We evaluated DOAC removal from plasma and elimination of DOAC interference in LAC testing by DF, and impact of DF on LAC assays in a representative patient cohort, including a comparison with DOAC-Stop (DS).

METHODS

Normal pooled plasma (NPP) was spiked with increasing concentrations of apixaban, rivaroxaban, edoxaban, and dabigatran. DOAC and LAC was measured on untreated, DF-treated, and DS-treated spiked samples. Coagulation parameters and thrombin generation were measured on patient samples (n = 20) before and after DF. Patients treated with DOAC, vitamin K antagonist, or heparin and nonanticoagulated patient samples (n = 139) were tested for LAC before and after DF.

RESULTS

In spiked NPP, levels were below the lower limit of quantification (LLoQ) after DF/DS treatment for all DOAC concentrations. Following DF, levels were below LLoQ for 53 of 56 DOAC-containing patient samples. Twenty-eight of 33 LAC-positive DOAC-containing samples became negative after filtration, whereas 5 remained LAC-positive (1/5 from a patient with antiphospholipid syndrome [APS]). Four LAC-positive DOAC-containing samples (from patients without APS), became negative after filtration, whereas they remained LAC positive after DS. In the non-DOAC patient groups following DF, LAC changed from positive to negative in 8 (due to a procoagulant effect) and vice versa in 2 cases.

CONCLUSION

DF reduces DOAC interference in LAC testing. As incomplete DOAC removal may occur, DOAC measurements should be performed after filtration. A procoagulant effect after filtration may lead to erroneous LAC results in non-DOAC-containing samples. Therefore, using DF should be restricted to DOAC-containing samples.